Miconazole 1 kit
Miconazole nitrate 1200 mg (in vaginal insert)
Miconazole nitrate 2% (external cream)
For vaginal use only
Do not use
if you have never had a vaginal yeast infection diagnosed by a doctor
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Questions or comments?
CONSUMER INFORMATION LEAFLET
Miconazole Nitrate Vaginal Insert (1200 mg) andMiconazole Nitrate Cream (2%)
Cures Most Vaginal Yeast Infections and Relieves Associated External Itching and Irritation
Why should I use this product?
This product contains a 1-dose vaginal insert that cures most vaginal yeast infections, plus an external cream that can be used for relief of itching and irritation on the skin outside the vagina (vulva) due to a yeast infection. Do not use this product if this is the first time you have vaginal discharge, itching, burning and discomfort. See your doctor or health professional firstto find out the cause of your symptoms. If a doctor has told you in the past that you had a vaginal yeast infection and you have the same symptoms now (such as vaginal discharge, itching or burning), then this product may work for you.
What is a vaginal yeast infection?
A vaginal yeast infection is a common condition caused by an overgrowth of yeast (Candida) that may normally live in the vagina. Your doctor may call this infection monilia or candidiasis. Some women may have a yeast infection on the skin outside of the vagina (vulva) at the same time that they have a vaginal infection.
Who can get a vaginal yeast infection?
You can get a vaginal yeast infection at any age. It is most common during the childbearing years. Women who are pregnant or diabetic, taking antibiotics, birth control pills or steroids, or who have a weakened immune system are more likely to get repeated yeast infections that may not clear up easily with proper treatment.
Some medical conditions can weaken the body's normal ability to fight infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV - the virus that causes AIDS). The HIV virus causes the body to be more likely to get infections, including vaginal yeast infections that may not clear up easily with proper treatment. If you may have been exposed to HIV and get repeated vaginal yeast infections, you should see your doctor right away. For more information on HIV infection, please contact your doctor or the CDC National AIDS HOTLINE. The CDC phone numbers are: 1-800-232-4636 (English/Spanish), or 1-888-232-6348 (hearing impaired, TTY).
How can I tell if I have a vaginal yeast infection?
When you have a vaginal yeast infection, you may have one or more of the following symptoms:
Note: Vaginal yeast infections do NOT cause fever, chills, lower abdominal, back or shoulder pain, foul-smelling vaginal discharge, or a missed period. These may be signs of a sexually transmitted disease (STD) or a tubal pregnancy. If you have these symptoms, call your doctor right away.
What are other causes of a vaginal discharge?
It is normal to have a small amount of vaginal discharge at certain times of the month. This normal discharge may be clear or slightly white and does not cause itching, pain or a foul odor.
The most common cause of an abnormal vaginal discharge is an infection. These infections include bacterial vaginosis (BV), trichomoniasis (Trich), gonorrhea (GC) and/or chlamydia. All of these may be transmitted sexually and are called sexually transmitted diseases (STDs). If you have more questions about sexually transmitted diseases (STDs) call the CDC STD Hotline at 1-800-227-8922.
Although many of the infections mentioned above can cause symptoms similar to a vaginal yeast infection (vaginal discharge, irritation and itching), their diagnosis must be made by a doctor so that proper treatment can be given.
If these infections are not properly treated or if proper treatment is delayed, serious problems, such as pelvic inflammatory disease (PID) may result, which may prevent you from having children in the future. If you are pregnant and do not get the proper treatment, the infection may be passed to your baby before or during delivery and may cause your baby to have permanent damage. If you have multiple sex partners or a new sex partner, you should also ask a doctor before use to make sure you do not have an STD.
Why do women get repeated vaginal yeast infections?
Women may get repeated vaginal yeast infections that may not clear up easily with proper treatment. Listed below are some of the causes of repeated yeast infections:
If you get vaginal yeast infections often (such as once a month or 3 in 6 months), you should talk to a doctor.
Are vaginal yeast infections sexually transmitted?
Vaginal yeast infections are usually not spread by having intercourse (sex). However, if your partner has a rash, itching or discomfort in his genital area, he should contact a doctor to find out the cause of his symptoms and tell the doctor that you are treating your vaginal yeast infection with this product.
How can I prevent repeated vaginal yeast infections?
To lower your chances of getting another yeast infection:
(1) Wear cotton underwear and loose-fitting clothes.
(2) Change out of damp clothes or a wet bathing suit as soon as possible.
(3) If you use minipads when you are not having a menstrual period, change the minipads often.
Can I use this product during my menstrual period?
Yes, this product can be used during your menstrual period. In fact, many women get vaginal yeast infections just before their period because of hormonal changes. Using this product during your period will not affect how well this product works. If you have started treatment and your period occurs, you should complete the full course of treatment.
Do not use tampons while using this product, because tampons may remove some of the drug from the vagina. Use deodorant-free sanitary napkins or pads instead, and change them often.
Can I use other vaginal products with this product?
This drug should notbe used with other vaginal products.
How can I get the best results when treating my infection?
What warnings should I know about when using this product?
For vaginal use only.
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Ask a doctor before use if you have:
Ask a doctor or pharmacist before use if you aretaking the prescription blood thinning medicine, warfarin (coumadin), because bleeding or bruising may occur.
When using this product:
How Should I Use Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%) Combination Pack?
This product is for adults and children 12 years of age and over. For children under 12 years, ask a doctor.
Directions for using the Applicator and the Vaginal Insert:
1Open pouch and remove contents. (see picture). KEEP CONTENTS DRY BEFORE USE. OPEN FOIL POUCH JUST BEFORE USE.
2Place the vaginal insert firmly into the top (wider end) of the applicator so it will not fall out.
3Hold the applicator containing the vaginal insert by the opposite end from where the vaginal insert is located.
4Gently insert the applicator into the vagina as far as it will go comfortably. This can be done while standing with your feet spread a few inches apart and your knees bent. Or, you can lie on your back with your knees bent, as shown in the picture.
5With one hand holding the barrel, use the other hand to push the plunger all the way in to place the vaginal insert as far back in the vagina as possible. Then remove both parts of the applicator from the vagina.
6Throw away applicator after use. Do not flush in toilet.
You may want to use deodorant-free pads or pantyshields to protect your clothing during the time that you are using this product. This is because the vaginal insert can leak or you may get some discharge. Do not use tampons, douches, spermicides, condoms or diaphragmsuntil after you have completed the treatment and your symptoms are gone.
Directions for using the External Vulvar Cream
Use the cream twice daily, for up to 7 days as needed.
1.Open the tube by unscrewing the cap. The first time the tube is opened, press the sharp point of the cap into the sealed end of the tube. Push down firmly until the seal is open.
2.Squeeze a small amount of cream onto your fingertip.
3.Apply the cream onto the skin outside the vagina (vulva) that itches and it irritated.
4.Screw the cap back on the tube.
5.Repeat steps 2-4, up to two times daily, as needed.
Stop use and ask your doctor if:
These may be signs that this product is not working, or you may have a more serious condition or an allergic reaction.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
What side effects may occur with this product?
A mild increase in vaginal burning, itching, or irritation may occur when the vaginal insert is inserted. Abdominal cramping has also been reported.
Stop using this product and consult your doctor if you have abdominal pain, hives, skin rash, or if you have severe vaginal burning, itching, or irritation or swelling.
What should I do if I have questions about this product?
Questions of a medical nature should be taken up with your doctor. If you have any other questions or need more information on this product, call our toll-free number 1-800-719-9260.
Vaginal Insert: miconazole nitrate, 1200 mg.
External Vulvar Cream: miconazole nitrate, 2%.
Vaginal Insert: fractionated coconut oil, gelatin, glycerin, lecithin, light mineral oil, purified water, titanium dioxide, white petrolatum
External Vulvar Cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
Allegan, MI 49010
: 19900 00 J2
Ingredients and appearance - Product information
Miconazole 1 kit- Miconazole nitrate
|Product Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 42507-737|
|Route of Administration||Vaginal|
|Color||WHITE (to off white, viscous)|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
Labeler - HyVee Inc( 006925671)
Principal display panel
1-Day Treatment Combination Pack
1 Vaginal Softgel Insert with 1 Applicator Plus External Cream for Itch Relief and 3 Soothe Wipes®
Multi-Symptom Relief & Treatment
Daytime or Nighttime Stays In Place
Cleanse & Soothe
3 Soothe Wipes® With Aloe & Vitamin E
Relieve Itching & Irritation
1 Tube of External Cream
Treat the Infection
1 Softgel Vaginal Insert and 1 Applicator
COMPARE TO the Active Ingredients of Monistat® 1
Miconazole Nitrate Vaginal Insert (1200 mg) And Miconazole Nitrate Cream (2%)
Vaginal Antifungal Combination Pack With 3 Soothe Wipes®
Cures Most Vaginal Yeast Infections and Relieves Associated External Itching and Irritation
1 Vaginal Softgel Insert with 1 Applicator Plus External Cream
Plus 3 Soothe Wipes®
NET WT 1 VAGINAL SOFTGEL INSERT + 0.32 OZ (9 g) TUBE